A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
ConditionAdvanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer. TAK-188 may help to remove these Tregs. Removing these Tregs may allow more cancer-fighting cells (CD8+ T cells) to attack the tumor and potentially stop tumors from growing.
In this study, researchers want to learn if TAK-188 can help the body's immune system better fight cancer in adults with advanced cancers which have not gotten better with regular treatments. The main aims of this study are to check if TAK-188 is safe in adults with advanced or spreading (metastatic) solid tumors, if participants tolerate the treatment with TAK-188 and to learn if TAK-188 works well in adults with certain advanced cancers after their previous treatments didn't work. Participants may receive TAK-188 for up to 1 year. Their health will be monitored after the treatment has ended for up to another year.
Eligibility criteria
Qualifiers
Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants must provide biopsy samples (core needle or other surgical procedure) collected within 28 days prior to C1D1 and also on treatment unless procedure is determined to be unsafe following discussion with sponsor. Participants with an archival biopsy specimen collected within 90 days prior to C1D1 of TAK-188 who have not received any other cancer-specific treatment (with the exception of adjuvant endocrine therapy for a history of breast cancer) at least 14 days prior to the biopsy and throughout the period leading up to C1D1 may use that archival specimen in lieu of a new pretreatment biopsy. Archival biopsy from the same tumor must be provided, if available.
Absolute neutrophil count (ANC) ≥1500 per microliter (μL), platelet count ≥75,000/μL, and hemoglobin (Hgb) ≥8.0 g/dL without growth factor support for ANC or transfusion support for platelets within 14 days before the first trial treatment dose. Transfusion of packed red blood cells is allowed, post infusion Hgb must be greater than 8.0 g/dL.
Disqualifiers
Congestive heart failure New York Heart Association Grade III or IV.
Unstable angina, myocardial infarction.
Persistent hypertension ≥160/100 mm mercury (Hg) despite optimal medical therapy.
Ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia).
Trial design
Treatments tested in this trial
- TAK-188
Treatment groups
223 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov